Ortho Solutions Inc
Ortho Solutions Inc has 3 FDA enforcement events on this register (3 product records) between 2015 and 2017: 3 device; the busiest year was 2015 with 1.
0% of its events are Class I; the most common class is Class II (3). 0 events are listed as ongoing; the recalling firm's address is in NJ.
Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.
Enforcement events
| Initiated | Product (first record) | Type | Class | Records | Status |
|---|---|---|---|---|---|
| 19 Apr 2017 | Oxford/Oxbridge AFN End Cap 10 mm x 5 mm tp 12 mm x10 mm The end caps are a circular disk with a small threaded shaft to be screwed to the distal end of the Nail. | Device | Class II | 1 | Terminated |
| 21 Jul 2016 | FPS 35mm x 3.5 mm non-locking screw | Device | Class II | 1 | Terminated |
| 14 Jul 2015 | Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw | Device | Class II | 1 | Terminated |
By type and class
Class I: 0% of this firm's events; 18% of all events on the register.
Events by year
Questions and answers
How many FDA recalls has Ortho Solutions Inc had?
3 enforcement events (3 product records) on this register, 2015–2017: 3 device.
Are any Ortho Solutions Inc recalls ongoing?
0 events are listed as ongoing in the current openFDA export.
What class are Ortho Solutions Inc recalls?
3 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.
Where does this data come from?
openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.
Provenance
Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.